---
kind: "section"
citation: "21 C.F.R. § 874.4450"
title: "21"
number: "874.4450"
heading: "Powered insertion system for a cochlear implant electrode array."
url: "https://uscodex.org/cfr/21/874.4450"
---

# §874.4450. Powered insertion system for a cochlear implant electrode array.

- (a) **Identification.** A powered insertion system for a cochlear implant electrode array is a prescription device used to assist in placing an electrode array into the cochlea.
- (b) **Classification.** Class II (special controls). The special controls for this device are:
  - (1) Clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use, including evaluation of all adverse events.
  - (2) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. Testing must include:
    - (i) Verification of cochlear implant attachment force, release force, and insertion speed;
    - (ii) Testing to demonstrate the device does not damage or degrade the cochlear implant (including the lead and array portions of the cochlear implant); and
    - (iii) **Comparison testing with manual insertion to evaluate—**
      - (A) Differences in cochlear implant array insertion force associated with use of the device; and
      - (B) Intracochlear placement of the cochlear implant array (intended scala placement and array insertion depth, together with minimal array tip foldover and cochlear scala translocation).
  - (3) Usability testing in a simulated hospital environment with an anatomically relevant model (e.g., cadaver testing) that evaluates the following:
    - (i) Successful use to aid in placement of the electrode array into the cochlea; and
    - (ii) **Harms caused by use errors observed.**
  - (4) Changes in cochlear implant compatibility are determined to significantly affect the safety or effectiveness of the device and must be validated through performance testing or a rationale for omission of any testing.
  - (5) The patient-contacting components of the device must be demonstrated to be biocompatible.
  - (6) Performance testing must demonstrate the electromagnetic compatibility, electrical safety, and thermal safety of the device.
  - (7) The patient-contacting components of the device must be demonstrated to be sterile and non-pyrogenic.
  - (8) Performance testing must support the shelf life of device components provided sterile by demonstrating continued sterility, package integrity, and device functionality over the labeled shelf life.
  - (9) Software verification, validation, and hazard analysis must be performed for any software components of the device.
  - (10) Labeling must include:
    - (i) The recommended training for the safe use of the device;
    - (ii) Summary of the relevant clinical and non-clinical testing pertinent to use of the device with compatible electrode arrays; and
    - (iii) **A shelf life.**

## Notes

### Amendments

[88 FR 979, Jan. 6, 2023]

### Authority

Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360 l, 371.

### Source

Source: 51 FR 40389, Nov. 6, 1986, unless otherwise noted.

### Amendments

[88 FR 979, Jan. 6, 2023]